Czech Republic

At present, the field of medical devices in the Czech Republic is regulated by two acts (Act No. 89/2021 Coll., Act No. 268/2014 Coll.), one government regulation (Government Regulation No. 56/2015 Coll.) and two decrees of Ministry of Health (Decree No. 62/2015 Coll., Decree No. 186/2021 Coll.).

Act No. 89/2021 Coll., on medical devices, is a regulation directly related to Regulation (EU) 2017/745 (MDR) and specifies the areas where Regulation (EU) 2017/745 gives freedom to individual Member States, and further regulates areas such as the use of medical devices (MD), prescribing and dispensing MD, service MD and other activities.

Act No. 268/2014 Coll., on in vitro diagnostic medical devices, is a legislative regulation which implements the requirements of EU Directive 98/79 / EC in the Czech Republic (together with Government Regulation No. 56/2015 Coll., on technical requirements for diagnostic in vitro medical devices). With the full effect of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in May 2022, this Act No. 268/2014 Coll. repealed together with a government regulation. Act No. 89/2021 Coll. will be amended to follow the EU Regulation 2017/746 and the area of MD will be regulated in the Czech Republic again by one act. We will inform you about changes in the area of legislative regulations on these websites.

MeDeCorp can help you with:

  • registration in the RZPRO system (Register of Medical Devices),
  • by announcing / extending the activity in the RZPRO system,
  • registration of medical devices in the RZPRO system,
  • overall management of RZPRO,
  • reporting adverse events.

As a MeDeCorp company, we will also respond to the change in reporting obligations with the launch of the EUDAMED database. We will keep you informed about all changes, so don’t forget to visit our website regularly. If you have other specific requirements concerning the regulation of the field of health care in the Czech Republic, do not hesitate to contact us with an inquiry and we will inform you whether we are able to meet your requirements. If you are interested, do not hesitate to contact us by email: or via the internet form at Based on your needs, we will find the best solution together.